In this study, the investigators hypothesize that the use of olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers is feasible in the Philippine setting. It will result in complete ulcer healing or wound closure after 16 weeks.

The specific aim of this study is to assess the feasibility of using olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers in the Philippines. The primary endpoint of which is to evaluate the efficacy of Olivamine on healing of chronic lower extremity ulcers which will be assessed by rate of change in ulcer size (wound healing trajectory) and proportion with complete ulcer healing (wound closure) at 4, 8, 16 and 16 weeks compared to baseline, week 0.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Potential study subjects will be patients who are 18 years or older, has confirmed with the informed consent. He/she has a non-healing lower extremity ulcers compromised due to underlying factors such as peripheral arterial disease, diabetes, venous insufficiency, and pressure. The ulcer must be between 1.0 cm2 and 10 cm2.

Criteria

Inclusion Criteria:

Patient is 18 years old or older.

Patient has a diagnosis of arterial, diabetic foot, venous insufficiency, or pressure ulcer or surgical and traumatic wound.

Patient's target study ulcer/wound and is ≥1.0 cm2 and ≤ 10.0 cm2 in size at the day of initial consult.

Study ulcer/wound has been present for greater than 6 weeks prior to initial consult.

Patients with Charcot foot deformities can be entered so long as the Charcot disease is not active, and the ulcer can be offloaded by an orthotic device.

The patient has adequate circulation to the lower extremity as evidenced by an ABI (measured by Doppler) of ≥ 0.7. If the patient has non-compressible leg arteries, as documented by an ABI >1.3, then the patient must have a Toe-Brachial Index be > 0.6, or a toe pressure >50 mm Hg.

Patient must have adequate in-home support to comply with all protocol-mandated visits and procedures, offloading or pressure redistribution as required, and proper application of study products and wound care regimen.

Patient or his/her legal representative has read and signed the Institutional Review Board-approved Informed Consent form before Screening.

Exclusion Criteria:

An ulcer/wound that is ≥10.0 cm2 and ≤ 1.0 cm2 in size at the day of initial consult is not eligible for this study.

Patient has clinical evidence of gangrene or infection on any part of the affected foot.

The patient is judged by the investigator or study staff to be unable or unlikely to comply with daily wound care instructions, or study visits.

Patient has known sensitivity or allergy to any component of the study product - Olivamine10.

Patient has one or more medical condition(s), including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the - Investigator would make the patient an inappropriate candidate for this wound healing study.

Patient has a malignant disease (other than squamous or basal cell carcinoma of the skin) not in remission for five years or more.

Patient has known alcohol or drug abuse.

Patient has a hematocrit greater than 60% or less than 27%.

Patient's diabetes is under poor control as manifested by HbA1c of >10.0%.

Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study.

Patient is using tobacco, or is exposed to a current smoker in their household. Patients may participate in the study if they have not used tobacco for 3 months and have not had a smoker in their household for 3 months.

Patient is using any form of nicotine including nicotine patches, gums, or sprays.

Patient has Acquired Immunodeficiency Syndrome (AIDS) or is known to be infected with Human Immunodeficiency Virus (HIV).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657318